Wearable apparatus for the treatment or prevention of osteopenia and osteoporosis, stimulating bone growth, preserving or improving bone mineral density, and inhibiting adipogenesis

ABSTRACT

A wearable apparatus for the treatment or prevention of osteopenia or osteoporosis, stimulating bone growth, preserving or improving bone mineral density, and inhibiting adipogenesis is disclosed where the apparatus may generally comprise one or more vibrating elements configured for imparting repeated mechanical loads to the hip, femur, and/or spine of an individual at a frequency and acceleration sufficient for therapeutic effect. These vibrating elements may be secured to the upper body of an individual via one or more respective securing mechanisms, where the securing mechanisms are configured to position the one or more vibrating elements in a direction lateral to the individual, and the position, tension, and efficacy of these vibrating elements may be monitored and/or regulated by one or more accelerometers.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2013/074296 filed Dec. 11, 2013, which claims the benefit ofpriority to U.S. Provisional Patent Application Nos. 61/797,844 filedDec. 17, 2012 (now Expired) and 61/873,246 filed Sep. 3, 2013 (nowExpired), each of which is incorporated herein by reference in itsentirety.

This application is further related to U.S. Provisional PatentApplications Nos. 61/464,619 filed Mar. 7, 2011 and 61/744,030 filedSep. 17,2012; U.S. patent application Ser. No. 13/414,011 filed Mar. 7,2012 (U.S. Publication No. 2013/0030262) and Ser. No. 13/414,307 filedMar. 7, 2012 (U.S. Publication No. 2013/0066166); and InternationalApplication Nos. PCT/US2012/028071 filed Mar. 7, 2012 (Publication No.WO 2012/122267) and PCT/US2012/069262 filed Dec. 12, 2012 (PublicationNo. WO 2013/106155), each of which is incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

The present invention relates generally to the stimulation of bonegrowth, healing of bone tissue, and treatment and prevention ofosteopenia, osteoporosis, and chronic back pain, and to preserving orimproving hone mineral density, and to inhibiting adipogenesisparticularly by the application of repeated mechanical loading to bonetissue.

BACKGROUND OF THE INVENTION

Low hone mineral density (BMD) and osteoporosis are significant problemsfacing the elderly, leading to 1.5 million fractures in 2002 (NationalOsteoporosis Foundation (NOF): America's bone health: The state ofosteoporosis and low bone mass in our nation. Washington DC, NationalOsteoporosis Foundation, 2002). Bisphosphonates, a class of compoundsthat generally inhibit the digestion of bone, have been used for over adecade to treat osteoporosis with significant success but cause unwantedside effects including osteonecrosis of the jaw, erosion of theesophagus, and atypical femoral fractures, which has lead to thereconsideration of the use of bisphosphonate therapy.

One alternative to treat osteoporosis has been the use of Whole BodyVibration (WBV), which consists of repeated mechanical loading of bonetissue through vibration devices, using, relatively high frequencies(e.g. 15-90 Hz) and relatively low mechanical loads (e.g. 0.1-1.5 g's).Studies have shown that WBV can delay and/or halt the progression ofosteoporosis (Rubin et. al,, Journal of Bone and Mineral Research,19:343-351, 2004). In another randomized study, in which ≧0.6 g's ofvibratory force were delivered to the feet of the patient, it wasdemonstrated that WBV was effective in improving hip BMD outcomes ascompared to control groups that either did not exercise or were part ofan exercise program (Verschueren et al., Journal of Bone and MineralResearch, 19:352-359, 2004).

Related studies have demonstrated the ability of WBV to improve hip andpreserve spine BMD in populations of healthy cyclists, postmenopausalwomen and disabled children (Am J Phys Med Rehabil 2010; 89:997-1009,Ann Intern Med 2011; 155:668-679, J Bone and Mineral Research 2011; 26(8):1759-1766).

The mechanism by which WBV influences BMD is an issue of some debate butstudies have suggested that the shear stress within bone marrow intrabecular architecture during high frequency vibration could providethe mechanical signal to marrow cells that leads to bone anabolism(Journal of Biomechanics 45 (2012):2222-2229). More specifically, shearstress above 0.5 Pa is mechanostimulatory to osteoblasts, osteoclastsand mesenchymal stem cells (Journal of Biomechanics 45(2012):2222-2229).

Many conventional methods of promoting bone tissue growth and bonemaintenance by the application of WBV generally tend to apply relativelyhigh frequency (e.g. 1.5-90 Hz) and relatively low magnitude mechanicalloads (e.g. 0.1-1.5 g's) to bodily extremities, such as the use ofvibrating platforms upon which a user stands that apply repeatedmechanical loads to the feet of a user. Current WBV vibration platforms(e.g. Galileo 900/2000™, Novotec Medical, Pforzheim, Germany; or PowerPlate™, Amsterdam, The Netherlands) and associated treatment regimensrequire the user to stand on a platform for up to 30 minutes a day,which is inconvenient for many users. Furthermore, applying vibration tothe feet of the patient is an inefficient method for mechanicallyloading the hips, femur, and spine, the targeted areas for WBV therapyfor osteoporosis. Up to 40% of vibration power is lost between the feetand the hips and spine due to mechanical damping in the knees and ankles(Rubin et al., Spine (Phila Pa. 1976), 28:2621-2627, 2003).

One other issue with current WBV platforms is the directionality ofapplied force. Standing on a vibrating platform, an individual receivesWBV stimulus in a plane perpendicular to the spine and long bones ofhip. Studies have shown that vibrations applied “in theinferior-superior direction would be misaligned with the principaltrabecular orientation in the greater trochanter and femoral neck,resulting in lower shear. In contrast, trabeculae in the lumbar spineare aligned with the direction of vibration and the permeability ishigher (Journal of Biomechanics 45 (2012):2222-2229).

There is a need for a more efficient and easy to use source ofmechanical vibration that delivers 0.6 g +/−0.5 g of force directly tothe spine and hips. A more efficient method for delivering vibrationforce would be to reduce the load applied to the patient and make thedevice easier to use, while maximizing therapeutic benefit toosteoporosis by localizing the repeated mechanical loads delivered tothe hip and spine. Additionally, the potential to deliver WBV in a planeparallel to the directionality of the spine and long bones of the hipmay be more beneficial than a traditional vibrating plate on which aperson stands.

Finally, the existing technology of vibrating platforms limits theapplication of WBV to special populations that may benefit from its use.Cyclists, for example, have been shown to have lower BMD than otherathletes and even lower than the BMD of sedentary people (Int J SportsMed 2012; 33:593-599). Thus, a wearable delivery system for thistechnology extends the reach of this tool to a wider population ofindividuals. Not only could a wearable device he used during cycling (orother activities), the present invention could be adapted to deliver WBVthrough a bicycle to the rider for the purpose of preserving BMD incyclists.

In a separate but connected issue, WBV have been suggested to be“anabolic to the musculoskeletal system” and “in parallel, suppressadiposity” (PNAS. Nov. 6, 2007; 104 (45):17879-17884). In animal models,studies have shown that low magnitude WBV can reduce stem celladipogenesis and can provide a tool for “nonpharmacologic prevention ofobesity and its sequelae” (PNAS. Nov. 6, 2007; 104 (45):17879-17884). Ina study done with obese women, WBV displayed a “positive effect on bodyweight and waist circumference reduction” (Korena J Fam Med. 2011;32:399-405).

SUMMARY OF THE :INVENTION

The present invention seeks to provide a novel method and apparatus forthe stimulation of bone growth, healing of bone tissue, and preventionof osteoporosis, osteopenia, and chronic back pain, as is described morein detail hereinbelow. The present invention may maintain or promotebone-tissue growth, may prevent the onset of osteoporosis, and may treatchronic back pain.

Contrary to the prior art, which attempts to induce WBV to the subjectwhile standing on a vibration platform or through other application ofWBV to bodily extremities, the present invention provides more effectivetreatment by targeted application of oscillating mechanical loads to thehip and spine of a user, as is described hereinbelow.

What is more, in distinction from the prior art, the present inventionallows for delivery of WBV stimulus in side-to-side, front-to-back,and/or in an inferior-superior directions. This flexibility in thedelivery system and the potential to load the bones of the spine andhips in more than just an inferior-superior plane (as is the case with avibrating platform), may allow for better targeting of the hips andspine in the treatment of osteoporosis and loss of BMD. Morespecifically in one variation, one or more vibrating elements may bepositioned against the patient's body via one or more securingmechanisms, respectively, which are configured to position the vibratingelements in a direction lateral to the individual's body such that themechanical loads are applied laterally to the patient rather than in aninferior-superior direction.

In one aspect of the present invention, a wearable apparatus fortreating osteoporosis and supporting BMD is provided, comprising one ormore vibrating elements configured for imparting repeated mechanicalloads to the hip and spine of an individual at a frequency andacceleration sufficient for therapeutic effect on osteoporosis; and oneor more securing mechanisms for securing said one or more vibratingelements to the upper body of said individual; wherein said one or morevibrating elements are configured for applying said repeated mechanicalloads to said individual's hip and spine.

In one embodiment of the present invention, the securing mechanisms ofthe apparatus attach to the shoulders of an individual to applyvibration to the back of the individual. In another aspect, additionalsecuring mechanisms attach to the waist of the individual to provideadditional support to the apparatus while it applies vibration to theback of the individual. In another embodiment, the securing mechanismsattach only to the waist or hips of an individual to apply vibration inthose locations. The location of applied vibration can thus be adjustedto preferentially deliver vibration to the spine, hips, or otherlocations.

In another aspect of the present invention, the device is worn aroundthe waist of the individual such that the vibrating element deliversvibration to the lower abdomen or lower back of the individual. Thisplacement maximizes the transmission of vibration to both the spine andthe hip.

In another aspect of the invention, the device can be configured to beworn around other parts of the body, including extremities such as thearms, legs, hand, feet, and head. This configuration is preferably ascaled-down version of the embodiment to be worn around the spine,waist, or hips.

In another embodiment, the apparatus further comprises a manuallysettable control for adjusting the frequency of said repeated mechanicalloads provided by said one or more vibrating elements. In anotherembodiment, the apparatus further comprises a manually settable controlfor adjusting the peak acceleration provided by said one or morevibrating elements.

In another embodiment, the peak acceleration is adjustable based onclosed-loop feedback from accelerometers around the patient's hips,spine, or other sites of interest. The vibrating elements are programmedto slowly increase the acceleration until the desired level is reached,then maintain that level for the rest of the treatment. In anotheraspect, the accelerometers are disposable, which ensures performance andprovides a recurring revenue stream for the company. In another aspect,the accelerometers are permanently mounted inside the pack itself.

In another embodiment, the relative readings of the variousaccelerometers ensure that the device is properly positioned and/ortensioned.

In another embodiment, the straps of the pack have force/tension sensorsin order to ensure the patient has securely attached the device beforebeginning treatment.

In another embodiment, said vibrating element comprises an oscillatingelement energized by an electrical power source. In another embodiment,said oscillating element comprises an oscillating mass that moves in aperiodic motion. In another embodiment, said vibrating element vibratesat a frequency in a range of about 15-90 Hz. In another embodiment, saidvibrating element generates peak acceleration in a range of about0.1-1.5 g. In another embodiment, said vibrating element is operative toinduce strain in bone tissue in a ramie of about 1-500 microstrain. Inanother embodiment, said vibrating element is operative to induce strainin bone tissue in a range of about 20-50 microstrain.

In another aspect of the invention, the pack has an internal timer thattracks the length of treatment and automatically turns the device offafter the treatment is complete. This feature can also be used toprevent excessive use of the device.

In another embodiment, the pack has internal memory which is used to logthe use of the device. Additionally, the pack has wired and/or wirelessconnectivity to other devices that can communicate with the patient, thepatient's family, and/or the patient's doctor. The other devices can becomputers, phones, tablets, watches, or any other similar device capableof displaying and sensing information. Logging information can be usedto track compliance and provide reminders to the patient when it is timefor a treatment session. This information can also be used as part of apoints-base rewards system to encourage the patients to use the device.

In another aspect of the present invention, a method for treatingosteoporosis is provided, comprising securing one or more vibratingelements to the upper body of an individual, wherein said one or morevibrating elements are configured to impart repeated mechanical loads tothe hip and spine of said individual at a frequency and accelerationsufficient for therapeutic effect on osteoporosis; and wherein said oneor more vibrating elements may impart said repeated mechanical loadsduring said individual's ambulation.

One embodiment of the present invention would include a mechanism fordelivering WBV through a bicycle to the rider for the prevention ofosteoporosis and supporting BMD.

Additionally, the present invention provides a wearable tool to use WBVfor the purpose of weight loss and decreasing adipogenesis.

INCORPORATION BY REFERENCE

All patents, patent applications, and other publications referred toherein are expressly incorporated by reference, to the same extent as ifeach individual publication, patent or patent application wasspecifically and individually indicated to be incorporated by reference.All documents cited are, in relevant part, incorporated herein byreference. However, the citation of any document is not to be construedas an admission that it is prior art with respect to the presentinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is an illustration of an exemplary embodiment of the presentinvention from an angled rear perspective.

FIG. 2 is an illustration of an exemplary embodiment of the presentinvention with two vibrating elements from the rear perspective.

FIG. 3 is an illustration of an exemplary embodiment of the presentinvention from an angled rear perspective.

FIG. 4 is a graph illustrating the ability to preferentially applyvibration to the spine or hips depending on where the present inventionis worn.

FIGS. 5A and 5B are graphs illustrating accelerations experienced at thehip and lumbar spine during normal use of the present invention.

FIG. 6 is a plot demonstrating the ability of the present invention toautomatically adjust the magnitude of acceleration based onaccelerometer feedback.

FIG. 7 is a picture of a preferred embodiment of the present inventionand its components.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides methods and apparatuses for thestimulation of bone growth, healing of bone tissue, and treatment andprevention of osteopenia, osteoporosis, and chronic back pain.

Exemplary embodiments of the apparatus of the present invention areillustrated in FIGS. 1-7 as follows.

FIG. 1 illustrates an apparatus for the stimulation of bone growth,prevention of osteopenia, healing of bone tissue, and treatment andprevention of osteopenia, osteoporosis, and chronic back pain 10,constructed and operative in accordance with an embodiment of thepresent invention. The apparatus 10 may include a vibrating elementconfigured for imparting repeated mechanical loads to the hip and spineof an individual at a frequency and acceleration sufficient fortherapeutic effect on osteoporosis 12. The vibrating element 12 may besecured to the upper body of an individual through one or more securingmechanisms 14. In such an arrangement, the vibrating element 12 may beconfigured for applying repeated mechanical loads to an individual's hipand spine.

Securing mechanisms 14 may be constructed in any shape and of anysuitable material. For example, the securing mechanisms 14 may be madeof any elastomeric material, such as but not limited to, cloth, woven ornon-woven, natural or synthetic rubber, silicone rubber, polyurethane,nylon, or polyester, with one or more enclosures for containing thevibrating element 12. The securing mechanisms 14 may be in the form of avest and may include one or more sleeves or shoulder straps for theupper extremities of the subject. The securing mechanisms may fasten thevibrating element 12 to the torso of an individual in any manner, suchas but not limited to, VELCRO, hooks, buckles, buttons, zippers, tying(e.g. laces), adhesive, and the like. The securing mechanisms may alsoattach to the shoulders, chest, abdomen, waist, hips, arms, legs, hands,feet, or head of an individual. The vibrating element 12 does not haveto be contained within an enclosure, and may be attached in any othermanner to the securing mechanisms 14, such as but not limited to, bybonding, embedding. etc. The securing mechanisms 14 may have any length,width and thickness.

Optionally, electronics may be embedded in the apparatus such that theelectronics enable communication between the apparatus and anotherdevice (e.g., a server, computer, communications device, smart phone,etc.) which may be remotely located. The electronics may be configuredto track and/or report compliance with a prescribed or recommended usagethrough wired or wireless protocols for reporting or communicating withthe other device.

The vibrating element 12 may be configured for imparting repeatedmechanical loads through any means known in the present art. Thevibrating element 12 may include an oscillating element energized by anelectrical power source. For example, an electromagnetic weight may beattached to a spring which is mounted for oscillating motion inside thevibrating element 12 and alternately attracted and repelled by asurrounding frame made of ferrous material, that is, an oscillating massthat moves in a periodic motion. It is understood that this is just oneexample of the vibrating 12 being energized by an electrical powersource 16. Another example of a vibrating element is an ultrasonictransducer that induces vibration of desired amplitude. Yet anotherexample of a vibrating element is a slider-crank mechanism (e.g. asdescribed in Zhang, Y. “Introduction to Mechanisms”, Carnegie MellonUniversity). Yet another example of a vibrating element is an eccentricmass attached to a motor that creates vibrations as it rotates.

The vibrating element may also be configured to impart repeatedmechanical loads in such a way that the frequency and amplitude ofacceleration are decoupled. In one embodiment, the vibrating elementmakes use of a clutch mechanism which is able to adjust the amplitude ofthe acceleration while the frequency remains constant. In anotherembodiment, the element makes use of a motor and eccentric weightattached to an adjustable-length moment arm. By adjusting the length ofthis moment arm, the amplitude of the acceleration can be adjustedindependently of the frequency. In yet another embodiment, multipleeccentric motors are used and designed to have interference that iseither constructive, destructive, or mixed. Depending on the setting,the motors are either be in phase, out of phase, or somewhere inbetween, which allows the amplitude of the acceleration to be adjustedwhile maintaining a constant frequency.

The vibrating element 12 may be configured for imparting repeatedmechanical loads to the hip and spine of an individual at a frequency ofbetween about 1-200 Hz and a peak acceleration of between about 0.1-10 g(where g=9.8 m/s) to induce strain in bone tissue of an individual in arange of about 1-500 microstrain. Alternatively, the vibrating element12 may vibrate at a frequency in a range of about 1-100 Hz, about 1-50Hz, about 5-35 Hz, about 20-50 Hz, or about 15-45 Hz. Alternatively, thevibrating element 12 may impart repeated mechanical loads at a peakacceleration of between about 0.1-5 g, about 0.3-1.5 g, about 0.6-1.5 g,or about 0.6 g. Alternatively, the vibrating element 12 may inducestrain in bone tissue in a range of about 50-500 microstrain, about1-250 microstrain, about 1-100 microstrain, or about 100 microstrain.However, the present invention is not limited to these values and otherranges of amplitude and frequency may be used.

The frequency of the applied repeated mechanical loads provided by thevibrating element 12 may be adjusted by an individual by a manuallysettable control. Alternatively, the peak acceleration of repeatedmechanical loads imparted by the vibrating element 12 may be adjusted byan individual by a manually settable control. The vibrating, element 12may be capable of being adjusted to any value or range of frequency orpeak acceleration as desired. The manually settable control may be inthe form of a rotating dial, one or more push buttons, one or moreswitches, or a computer interface. Additionally, the vibrating element12 may be suitably comfortable enough for patients to wear up to 10minutes (or longer) at a time.

The electrical power source 16 may be a battery (which may berechargeable) disposed in the vibrating element 14. Alternatively, theelectrical power source 16 may be external to the apparatus 10, such asbut not limited to, AC power or other power supply, and may be in wired(e.g., connected by an electrical range cord or any other kind ofelectrical connector or terminal) or wireless (e.g., radio frequency(RF), infrared, laser, Bluetooth, etc.) communication with the vibratingelement 12. In the case of a battery, a status LED or other means ofalert can be used to inform the user when the battery needs to bereplaced or charged.

FIG. 2 illustrates the apparatus 10 with multiple vibrating elements 12.The apparatus 10 may contain one, two, three, four, five, or more thanfive vibrating elements 12.

FIG. 3 illustrates the apparatus 10 with securing mechanisms 14 thatattach only to the waist or hips of an individual. This embodiment stillcomprises at least one vibrating element 12 and electrical power source16.

FIG. 4 illustrates the ability to preferentially deliver vibration tothe spine, hips, or other locations, depending on where the presentinvention is worn. The data were collected by attaching accelerometersto the skin directly superficial to the iliac crest (hip) and T7vertebra (spine) of a test subject, while the present invention was wornon the back, waist and hips of the subject. When worn on the back,vibrations are preferentially delivered to the spine of the individual.When worn on the hips, vibrations are preferentially delivered to thehips of the individual. When worn on the waist, vibrations arepreferentially delivered to the spine of the individual, althoughsignificant vibrations are also delivered to the hip. Therefore, thepreferred embodiment of the present invention is to be worn around thewaist of an individual. More specifically, the invention should beplaced over the lower abdomen and lower back to maximize transmission ofvibration to both the spine and the hip.

FIG. 5A further illustrates the accelerations experienced at the hip andlumbar spine during normal use of the present invention. With the deviceproperly positioned, acceleration magnitudes of around 0.6 g aredelivered, as measured by skin-mounted accelerometers.

The present invention may stimulate bone growth, maintain bone tissue,preserve or improve bone mineral density, and prevent osteoporosis andosteopenia in various bone regions of the hip (e.g. femoral head,femoral neck, greater trochanter, lesser trochanter, femur, anteriorsuperior iliac spine, etc.) and spine (e.g. cervical spine, thoracicspine, lumbar spine, sacrum, coccyx, etc.). Alternatively, the presentinvention may stimulate bone growth in bones in other parts of the body,as the vibrations carry to other parts of the body (e.g., bones in thevicinity of the legs, knees, or feet). Stimulation to other sites canalso be accomplished by using a scaled-down version of the presentdevice to directly stimulate the legs, arms, feet, hands, head, or anyother location.

In order to determine the vibration levels that the patient receiveswhen wearing the apparatus 10, accelerometers may be used with thepatient. For instance, bone-mounted accelerometers may be used althoughinvasive to the patient.

Alternatively, the present invention may also make use of feedback fromaccelerometers (e.g., triaxial accelerometers with a range of +/−3 gsuch as ADXL335, Analog Devices) to adjust the amplitude of accelerationdelivered to the patient. These accelerometers (which are incommunication with a processor, not shown) may be between the vibratingelement 12 and user's skin or in proximity to the vibrating element 12.Once the accelerometers are secured, the peak-to-peak acceleration maybe measured or monitored at, e.g., the hip (superficial to the rightiliac crest) and lumbar spine (first lumbar vertebra), along areas ofthe skin not covered by the device and optionally wrapped tightly withelastic bandages to secure the attachment. An example of anaccelerometer 17′ which may be used with the apparatus is illustrated inFIG. 3. While a single accelerometer 17′ is shown, multipleaccelerometers may be utilized if so desired. Moreover, the user ofaccelerometers 17′ may be utilized with any of the apparatus variationsas described herein. FIG. 5B illustrates the accelerations experiencedat the hip and lumbar spine using the accelerometers.

When turned on, the device can adjust the acceleration to the desiredlevel and maintain it during the course of the treatment. This featurealso allows for self-correcting of the pack if the straps loosen, thepatient changes posture, or any other event that may impact theacceleration felt by the patient. Alternatively, the accelerometers maybe a permanent part of the device. Though not as accurate asaccelerometers secured directly to the skin, this method still providesuseful information about the acceleration magnitude and can also be usedfor feedback control. An illustration of this is shown in FIG. 3, whichhas two pack-mounted accelerometers 17.

FIG. 6 shows a plot that demonstrates the ability of the presentinvention to adjust the magnitude of the acceleration based onaccelerometer-based feedback. At 60 seconds, the device is loosened suchthat the acceleration delivered to the patient has been diminished. At150 seconds, the device automatically adjusts to the loosening byincreasing the magnitude of the acceleration until it has returned tothe pre-loosening level.

The present invention may also make use of force or tension sensorsembedded in/on securing mechanisms 14. These sensors can providefeedback about the snugness of the device against the patient, whichaffects the efficiency of acceleration transmission. Preferably, thedevice provides an alert if the securing mechanisms are too loose,whether initially or due to loosening during a treatment session.

A preferred embodiment of the present invention is shown in FIG. 7,which illustrates the components that comprise the device. Components ofthe wearable vibration device include the waist-pack housing A, paddingB, motor housing C, battery D, eccentric weights E, DC motor F, surfacemount electrodes G, and computer chip with control software H.

The method and apparatus of the present invention enable the treatmentand prevention of osteoporosis in an individual in a standing, seated orany other upright static posture, as well as during ambulation or anyother activities of daily living, such as driving a car, driving anelectric wheelchair, or riding a train. Other advantages provided by themethod and apparatus of the present invention include the directapplication of repeated mechanical loads to the bones most at risk forfracture in osteoporosis, and bypassing the unnecessary mechanicalloading of the feet or knees as is done in vibrational platforms.Another advantage of the method and apparatus of the present inventionis that little or no training/learning is required of an individual toutilize the present invention.

Additionally, the present invention provides the advantage of having thepotential to deliver vibration stimulus to the spine and hips in morethan just an inferior-superior direction (but also transverse, orside-to-side, and front-to-back directions).

Although the present invention has been described with respect topreferred embodiments, it will be readily apparent to those havingordinary skill in the art to which it appertains that changes andmodifications may be made thereto without departing from the spirit orscope of the disclosure.

What is more, the wearable nature of the present invention provides forportable and battery-powered delivery systems for WBV, an issue notcontemplated in the current state of the an for vibration treatmentsystems.

In addition, one embodiment of the present invention would include amechanism for delivering WBV through a bicycle (e.g. stem, seat, pedals,handlebars) to support/preserve BMD in cyclists.

Additionally, the present invention is intended to be used for thepurpose of providing a wearable tool for weight loss, decreasing waistcircumference and decreasing adipogenesis.

The applications of the devices and methods discussed above are notlimited to the treatment of bone loss but may include any number offurther treatment applications. Moreover, such devices and methods maybe applied to other treatment sites within the body. Modification of theabove-described assemblies and methods for carrying out the invention,combinations between different variations as practicable, and variationsof aspects of the invention that are obvious to those of skill in theart are intended to be within the scope of the claims.

What is claimed is:
 1. A wearable apparatus for treating or preventingosteoporosis, comprising: one or more vibrating elements configured forimparting repeated mechanical loads to the hip, femur, and/or spine ofan individual at a frequency and acceleration sufficient for therapeuticeffect on osteoporosis; and one or more securing mechanisms for securingsaid one or more vibrating elements to the body of said individual,wherein said securing mechanisms are configured to position the one ormore vibrating elements in a direction lateral to the individual.
 2. Theapparatus according to claim 1, further comprising a manually settablecontrol for adjusting the frequency of said repeated mechanical loadsprovided by said one or more vibrating elements.
 3. The apparatusaccording to claim 1, further comprising a manually settable control foradjusting the peak acceleration provided by said one or more vibratingelements.
 4. The apparatus according to claim 1, wherein said vibratingelement comprises an oscillating element energized by an electricalpower source.
 5. The apparatus according to claim 4, wherein saidoscillating element comprises an oscillating mass that moves in aperiodic motion.
 6. The apparatus according to claim 1, wherein saidvibrating element vibrates at a frequency in a range of about 15-45 Hz.7. The apparatus according to claim 1, wherein said vibrating elementgenerates peak acceleration in a range of about 0.1-1.5 g.
 8. Theapparatus according to claim 1, wherein said vibrating element isoperative to induce strain in bone tissue in a range of about 1-500microstrain.
 9. The apparatus according to claim 1, wherein saidvibrating element is operative to induce strain in bone tissue in arange of about 20-50 microstrain.
 10. The apparatus according to claim1, wherein said vibrating element generates vibrations in the axisparallel to the spine.
 11. The apparatus according to claim 1, whereinsaid vibrating element generates vibrations in the axes perpendicular tothe spine.
 12. The apparatus according to claim 1, wherein saidvibrating element is worn over the lower abdomen or lower back of theindividual.
 13. The apparatus according to claim 1, further comprisingone or more accelerometers in proximity to the one or more vibratingelements.
 14. The apparatus according to claim 13, wherein the one ormore accelerometers comprise skin-mounted accelerometers.
 15. Theapparatus according to claim 13, wherein the one or more accelerometersensure proper positioning and/or tensioning of the apparatus.
 16. Theapparatus according to claim 1, wherein embedded electronics incommunication with the apparatus are configured to track and/or reportcompliance with a prescribed or recommended usage.
 17. A method fortreating or preventing osteoporosis, comprising: securing one or morevibrating elements to the body of an individual, wherein said one ormore vibrating elements are configured to impart repeated mechanicalloads to a hip, femur, and spine of said individual at a frequency andacceleration sufficient for therapeutic effect on osteoporosis; andapplying the repeated mechanical loads to the hip, femur, and spine in alateral direction relative to the individual's body, wherein said one ormore vibrating elements impart said repeated mechanical loads duringsaid individual's ambulation.
 18. The method according to claim 17,further comprising monitoring the frequency and acceleration via one ormore accelerometers.
 19. The method according to claim 17, furthercomprising ensuring proper positioning and/or tensioning of the one ormore vibrating elements via one or more accelerometers.
 20. The methodaccording to claim 17, wherein applying comprises delivering therepeated mechanical loads through a stem, seat, pedals, or handlebars ofa bicycle.
 21. A method for treating obesity, decreasing waistcircumference and/or decreasing adipogenesis, comprising: securing oneor more vibrating elements to the body of an individual, wherein saidone or more vibrating elements are configured to impart repeatedmechanical loads to a hip, femur, and spine of said individual at afrequency and acceleration sufficient for therapeutic effect on obesity;and applying the repeated mechanical loads to the hip, femur, and spinein a lateral direction relative to the individual's body, wherein saidone or more vibrating elements impart said repeated mechanical loadsduring said individual's ambulation.
 22. An apparatus for preservingbone mineral density in cyclists, comprising: one or more vibratingelements configured for imparting repeated mechanical loads through abicycle to a rider at a frequency and acceleration sufficient fortherapeutic effect on osteoporosis; wherein said one or more vibratingelements are configured for applying said repeated mechanical loads tosaid individual's hip, legs and/or spine.
 23. A method for facilitatingnormal bone maturation, comprising: securing one or more vibratingelements to the body of an individual, wherein said one or morevibrating elements are configured to impart repeated mechanical loads toa hip, femur and spine of said individual at a frequency andacceleration sufficient for therapeutic effect on bone maturation; andapplying the repeated mechanical loads to the hip, femur and spine in alateral direction relative to the individual's body, wherein said one ormore vibrating elements impart said repeated mechanical loads duringsaid individual's ambulation.